Verifica della corretta applicazione delle norme di classificazione ed etichettatura dei preparati pericolosi. Maristella Rubbiani

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1 Verifica della corretta applicazione delle norme di classificazione ed etichettatura dei preparati pericolosi Maristella Rubbiani

2 Summary legal base and definition classification of preparations dilution and additivity concept criteria for labelling practical experiences

3 General provisions: Directive 1999/45/EC Preparations Directive classification packaging labelling safety data sheets delivery of information relating to health

4 Regulation of the European Parliament and of the Council On classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006 (CLP) GHS

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11 Dilution effect : environment

12 L(E)C 50 value of the substance(s) (mg/l) (M factor) Classification of Preparation: N, R50-53 N, R51-53 R < L(E)C 50 1 C n 25% C n 2.5% C n 0.25% 0.01 < L(E)C C n 2.5% C n 0.25% C n 0.025% < L(E)C C n 0.25% C n 0.025% C n % < L(E)C C n 0.025% C n % C n % < L(E)C C n % C n % C n % (continue in factor of 10 intervals)

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21 SYMBOLS PHYSICAL CHEMICAL HAZARDS HAZARDS TO HUMAN HEALTH HAZARDS TO ENVIRONMENT

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26 LABELLING ELEMENTS: 1. SYMBOLS 2. RISK PHRASES 3. SAFETY PHRASES Very toxic to aquatic organisms This material and its container must be disposed as hazardous waste

27 LABELLING ELEMENTS: 1. PICTOGRAMS 2. SIGNAL WORDS 3. HAZARD STATEMENTS 4. PRECAUTIONARY STATEMENTS Very toxic to aquatic life WARNING Avoid release to the environment. Collect spillage. Dispose of contents/container to

28 RISK PHRASES HAZARD STATEMENTS ACUTE TOXIC VERY TOXIC ORAL R28: Very toxic if swallowed EXPLOSIVES R2: Risk of explosion by shock, friction, fire other sources of ignition ACUTE TOXIC CATEGORY 1 ORAL H300: Fatal if swallowed EXPLOSIVES DIVISION 1.2 H202: Explosive, severe projection hazard

29 SAFETY PHRASES PRECAUTIONARY STATEMENTS ACUTE TOXIC VERY TOXIC ORAL S36/37: Wear suitable protective clothes and gloves EXPLOSIVES S2: Keep out of reach of children CATEGORY 1 ACUTE TOXIC ORAL P264: Wash thoroughly EXPLOSIVES DIVISION 1.2 P370+P380: In case of fire: evacuate area

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31 THE LABELS? WHERE? +

32 Label for preparation

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34 Substance name in Annex I to DSD 67/548/EC Links: Search Annex 1 Or try enter CAS No or EC No (searching by name or mol. formula is not reliable: see negative result for permethrin ) if CAS and EC Nos are unknown, go to: Select an item search Annex 1

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41 Practical Experiences Responsibility: The responsibility in the supply chain is often unclear Preparations foreseen for professional use are often also used by general public (esp. smaller amounts) Classification and Labelling: Nearly no correct labelling because of technically difficult legislation To distinguish between preparations intended for professional use and consumer use is sometimes impossible To verify the classification of a preparation is sometimes complicated because the information of the compositions is given in concentration intervals To collect info (as updated MSDS) for all the components is often complicate The classification of preparations according to some phys-chem (es. oxidising properties) is difficult

42 Practical Experiences Packaging The safety of the packaging will not always be guaranteed for consumers because the transport rules do not cover all safety aspects during the normal use of a chemical Missing child resistant fastening is sometimes claimed to be due to non-public sale Tactile warning of danger is very often missing Safety Data Sheet Difficulties to control the liability of the MSDS is considered as a very big problem The information content in the MSDS is large but often of poor quality MSDS very often not updated Chapter 15 (Classification) of the MSDS often does not correspond to the label Recommendations: It should be ensured on legal base that the person who is responsible for classification and labelling gets the therefore sufficient information from the supplier ( Right to Know ) Inspectors should have full access to the complete composition ensured by EU legislation (even when the producer is located in another MS) A concentration limit for oxidising components would be valuable to classify preparations according to oxidising properties The provisions concerning packages should be revised under consideration that transport provisions probably may not fully meet the needs for handling and use

43 WHO IS RESPONSIBLE IN THE SUPPLY CHAIN THE ONE PLACING THE SUBSTANCE OR MIXTURE ON THE MARKET MUST CLASSIFY AND LABEL IN ACCORDANCE WITH DIRECTIVE 67/548 and 99/45 PLACING ON THE MARKET MEANS MAKING AVAILABLE TO THIRD PARTIES. IMPORTATION INTO THE COMMUNITY CUSTOMS TERRITORY SHALL BE DEEMED TO BE PLACING ON THE MARKET FOR THE PURPOSES OF THIS DIRECTIVE

44 PREPARATIONS: ALL PREPARATIONS ARE SUBJECT TO SELF-CLASSIFICATION IN ACCORDANCE TO THE CRITERIA IN DIRECTIVE 67/548 AND ADDITIONAL PROVISIONS FOR PREPARATIONS IN DIRECTIVE 1999/45 MIXTURES: ALL MIXTURES ARE SUBJECT TO SELF- CLASSIFICATION IN ACCORDANCE TO THE CRITERIA PROVIDED IN THE NEW REGULATION

45 PREPARATIONS (1999/45/EC) ALL PROVISONS UNDER THIS DIRECTIVE ARE INCLUDED UNDER THE NEW REGULATION WORKPLACE PROTECTION (98/24/EC) RESTRICTIONS ON MARKETING AND USE (76/769/EEC) SEVESO MAJOR ACCIDENT HAZARDS (96/82/EC) PLANT PROTECTION PRODUCTS (91/414/EEC) BIOCIDES (98/8/EC) HAZARDOUS WASTE (91/689/EC) COSMETICS (2003/15/EC) EXPORT-IMPORT (304/2003) and others

46 National register of Dangerous Preparations Art. 10 of the D.Lgs. N. 285/98 (implementing in Italy dir. 88/379) appoints ISS as the Governmental Organization charged for receiving information on marketed Dangerous Preparations, with particular reference to the full chemical composition. This provision is confirmed by the D.Lgs. N. 65/2003 implementing in Italy the dir. 1999/45/EC.

47 National register of Dangerous Preparations Establishing a Database of Dangerous Preparations based upon the provisions of art. 10 of dir. 88/379/EEC, listing the dangerous preparations present on National market, to be used only in view of preventive or therapeutic measures, particularly in emergency; Allowing the on-line consultation of the data bank only to the Poison Centres certified as suitable by fulfilling specific criteria concerning their structural and human resources, and being able to ensure the confidentiality of the sensitive data with the use of personalized keys of access;all the other Poison Centres can access the information through ISS or the certified Poison Centres; Constitution of a Permanent Working Group ISS-Poison Centres (PC)

48 NOTIFIED PREPARATIONS set-02 gen-04 mag-05 ott-06 feb-08 lug-09

49 Poison Center ISS Industry National Health System

50 REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006 Article 45. Appointment of bodies responsible for receiving information relating to health 1. Member States shall appoint a body or bodies responsible for receiving information by the suppliers, including chemical composition of the mixtures placed on the market and classified or considered as hazardous on the basis of their health effects or on the basis of their physical effects. 2. The appointed bodies shall provide all requisite guarantees for maintaining the confidentiality of the information received. Such information may only be used to meet medical demand by formulating preventative and curative measures, in particular in case of emergency. The information shall not be used for other purposes.

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